- Device
- Vercise Deep Brain Stimulation (DBS) Systems (Vercise Genus™ R32, Vercise Genus™ R16)
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S071
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2024-03-13
- Decision code
- OK30
- Date received
- 2024-02-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement changes to the Implantable Pulse Generator Laser Excise Printed Circuit Board Assembly manufacturing process